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U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2013

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Event Detail

Event ID 66992
Product Type Devices
Status Ongoing
Recalling Firm GE OEC Medical Systems, Inc
City Salt Lake City
State UT
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-26
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide Distribution

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
InstaTrak® 3500 Plus, ENTrakTM Plus, InstaTrak® 3500, ENTrakTM Computer-Assisted Navigation Systems (USA), Model Numbers IT2500,IT2500 Plus,IT3500, IT3500 Plus Class II GE OEC Medical Systems Inc is recalling InstaTrak® 3500 Plus, ENTrakTM Plus, InstaTrak® 3500, ENTrakTM Computer-Assisted Navigation Systems (USA) due to several potential safety issues related to the use of these products. 654 Z-0524-2014
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